Results 91 to 100 of about 7,093,593 (187)

Full GMP-Compliant Validation of Bone Marrow-Derived Human CD133+ Cells as Advanced Therapy Medicinal Product for Refractory Ischemic Cardiomyopathy [PDF]

, 2015
According to the European Medicine Agency (EMA) regulatory frameworks, Advanced Therapy Medicinal Products (ATMP) represent a new category of drugs in which the active ingredient consists of cells, genes, or tissues.
D. Belotti, B. Cabiati, G. Gaipa, E. Gambini, B. Bassetti, L. Cavallotti, A. Biondi, E. Biagi, G. Spaltro, M. Parma, G. Pompilio   +10 more
core   +1 more source

Technology forecast: advanced therapies in late clinical research, EMA approval or clinical application via hospital exemption

Journal of Market Access & Health Policy, 2019
Background: The umbrella term ATMPs (Advanced Therapy Medicinal Products) comprises cell therapies, gene therapeutics and tissue engineered products. After implementation of the Regulation 1394/2007, only a couple of products have obtained a centralized ...
Claudia Eder, Claudia Wild
doaj   +1 more source

Advanced therapy medicinal products (ATMPs) & GMP : 10 years after

, 2019
We review the GMP/regulatory experience with advanced therapy medicinal products (ATMPs) approximately 10 years after EC regulation 1394/2007, aka the ATMP regulation applied. Particularly, we discuss practical issues which have arisen during this period
Jossen, Valentin, Eibl-Schindler, Regine, Eibl, Dieter, van den Bos, Christian   +3 more
core   +1 more source

Current challenges and future directions of ATMPs in regenerative medicine

Regenerative Therapy
Advanced therapy medicinal products (ATMPs) represent a groundbreaking category of medications that utilize biological-based products to treat or replace damaged organs.
Fatemeh Abbasi Kakroodi, Elaheh Khodadoust, Marzieh Alizadeh, Reyhaneh Sadat Hayaei Tehrani, Pedram Asadi Sarabi, Mohammad Rahmanian, Massoud Vosough   +6 more
doaj   +1 more source

Shaping national networks to improve patient access to advanced therapy medicinal products in Europe

Advanced therapy medicinal products (ATMPs) offer the potential to address unmet medical needs, yet ensuring sustainable patient access remains challenging.
Regenerative Medicine and Stem Cells, Meij, Pauline, HEE Team 2, ten Ham, Renske M T, Broeders, Mike, Hoek, Joyce M, HEE, Main, Heather, Bloem, Lourens T, Hernandez, Juan Francisco, Warmerdam, Daniël O, RSNN SIG Advanced Therapies Steering Committee   +11 more
core   +1 more source

Designing integrated early-phase protocols to reduce substantial modifications, including considerations for patient cohorts – a multi-stakeholder consensus view for a practical approach in Germany

Frontiers in Pharmacology
• Frequent substantial modifications for initiating new trial parts slow down development and reduce transparency.• Combining healthy volunteers and patients in a single early-phase trial raises safety, feasibility, and regulatory concerns.• A multi ...
R. Schultz-Heienbrok, S. Baumann, R. Böhm, R. Böhm, A. Bonertz, K. Breithaupt-Groegler, U. Buckpesch-Heberer, M. Coenen, K. Erb-Zohar, N. Faisst, G. Grass, J. Höchel, A. Kovar, A. Muehlenbroich, J. Rengelshausen, C. Riedel, B. Schug, T. Sudhop, A. Warnke, B. Ziegele   +19 more
doaj   +1 more source

Integrating Artificial Intelligence for Academic Advanced Therapy Medicinal Products: Challenges and Opportunities

Applied Sciences
Cell and gene therapies represent promising new treatment options for many diseases, but also face challenges for clinical translation and delivery. Hospital-based GMP facilities enable rapid bench-to-bedside development and patient access but require ...
Cristobal Aguilar-Gallardo, Ana Bonora-Centelles   +1 more
doaj   +1 more source

The advanced therapy classification procedure

, 2011
The classification procedure, introduced by the European Regulation on advanced therapy medicinal products (ATMPs), has received a tremendous interest from companies, academic and public sponsors developing ATMPs.
Pinheiro, M-H, Papaluca-Amati, M, L. D’Apote, M. Boucaumont, Celis, P, P. Celis, M.-H. Pinheiro, Boucaumont, M, M. Papaluca-Amati, C. Voltz-Girolt, D'Apote, L, Voltz-Girolt, C   +11 more
core   +1 more source

Extracellular vesicles derived from clonal mesenchymal stromal cells preconditioned by indirect hypoxia modulate immune responses in diabetic mice more effectively than directly preconditioned vesicles

Stem Cell Research & Therapy
Background Mesenchymal stem/stromal cells (MSCs) or MSC-derived extracellular vesicles (MSC-EVs) are considered potential modulators of the immune system in type 1 diabetes (T1D) therapy.
Mehdi Soleymani-Goloujeh, Mahnaz Babaahmadi, Faezeh Shekari, Mojgan Barati, Nasrin Fallah, Mahmoud Alipour Choshali, Nima Makvnd Gholipour, Maryam Hezavehei, Masoumeh Azimi, Saeed Yakhkeshi, Samira Vesali, Saeed Mohammadi, Hossein Baharvand, Seyedeh-Nafiseh Hassani, Ensiyeh Hajizadeh-Saffar   +14 more
doaj   +1 more source

Successful transport across continents of GMP-manufactured and cryopreserved culture-expanded human fetal liver-derived mesenchymal stem cells for use in a clinical trial

Regenerative Therapy
Introduction: Cell therapy has been increasingly considered to treat diseases, but it has been proven difficult to manufacture the same product at multiple manufacturing sites.
Ashis Kumar, Sowmya Ramesh, Lilian Walther-Jallow, Annika Goos, Vignesh Kumar, Åsa Ekblad, Vrisha Madhuri, Cecilia Götherström   +7 more
doaj   +1 more source